# FDA 483 - Qilu SYNVA Pharmaceutical Co. Ltd - May 16, 2025

Source: https://www.keypedia.com/records/483/qilu-synva-pharmaceutical-co-ltd/bdf15cf8-cf9e-43ff-a233-1fdd59a871f8

> FDA 483 for Qilu SYNVA Pharmaceutical Co. Ltd on May 16, 2025. Product: veterinary. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Qilu SYNVA Pharmaceutical Co. Ltd
- Inspection Date: 2025-05-16
- Product Type: veterinary
- Office Name: Baltimore District Office
- Summary: During an FDA inspection conducted from May 12-16, 2025, Qilu SYNVA Pharmaceutical Co., Ltd., an Active Pharmaceutical Ingredient (API) manufacturer in Dezhou, Shandong, China, received a Form FDA-483 citing multiple significant observations regarding their manufacturing and quality control operations. Key issues included a lack of proper data integrity and quality assurance oversight, specifically with quality control lacking full approval responsibility for final testing results, and critical analytical data not being adequately preserved or documented. The inspection also identified failures in maintaining aseptic techniques during sterility testing, with technicians observed compromising sterile environments. Furthermore, laboratory controls for sterile testing areas were found to be inadequate, as smoke studies were conducted under static conditions, not simulating operational activities. The firm's raw material sampling procedures were deemed unrepresentative, lacking necessary detail for ensuring quality, and manufacturing equipment, particularly water systems, was improperly identified, impeding clear operational flow. These observations indicate potential non-compliance with the Federal Food, Drug, and Cosmetic Act's quality system requirements. Qilu SYNVA Pharmaceutical Co., Ltd. is required to thoroughly address these deficiencies, implement comprehensive corrective actions, and submit a detailed response to the FDA.

## Related Documents

- [483 - 2025-05-16](https://www.keypedia.com/records/483/qilu-synva-pharmaceutical-co-ltd/d5429ebd-a562-4752-85f4-d714c898528d)

## Related Officers

- [Investigator](https://www.keypedia.com/people/marvin-d-jones/3101a8da-f5c1-4e0c-b4b1-b09be181be36)

Company: https://www.keypedia.com/companies/qilu-synva-pharmaceutical-co-ltd/fda44d3b-5f42-4cde-9760-cf4147fc0ef8

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa